A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy

NCT01547585 | Completed

• 2 other identifiers: SOY-CVD-2012RBPI#1746
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 3

Brief Summary

This study is being conducted to test the hypothesis that daily consumption of a baked food product containing whole soy for 6 weeks will significantly reduce plasma Low Density Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall goals of this study are to determine whether daily consumption of muffins made from whole soy flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and physical characterization of certified defatted whole soy flour that will be incorporated into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical trial. All participants will be randomized into one of three groups and asked to eat two muffins daily for 6 weeks in the following combination: high dose soy; control group or low dose soy. Before, after, and mid-way during the feeding period, blood samples will be obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals. The effect of soy consumption on waist circumference, body mass index (BMI) and blood pressure will also be examined.

Conditions

Hypercholesterolemia; Cardiovascular Disease; CRP

Keywords

Cholesterol; Cardiovascular disease; Soy; Dose-response

Outcome Measures

Primary Outcomes (1)

• Low Density Lipoprotein Cholesterol (LDL-Cholesterol)

  6 weeks

Secondary Outcomes (1)

• high sensitivity c-reactive protein (hsCRP)

  6 weeks

Study Arms (3)

Control

PLACEBO COMPARATOR

\- Isocaloric control muffins

Other: Standardized soy containing muffin

Low Dose Soy

EXPERIMENTAL

\- Isocaloric muffins containing low dose of soy

Other: Standardized soy containing muffin

High Dose Soy

EXPERIMENTAL

\- Isocaloric muffins containing high dose soy

Other: Standardized soy containing muffin

Interventions

Standardized soy containing muffin OTHER

Standardized muffin containing two levels of soy

Also known as: Soy containing muffins

Control; High Dose Soy; Low Dose Soy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females (not pregnant or lactating) aged 30-70 year
• Body mass index (BMI) ≤40kg/m² and ≥18.5kg/m²
• Fasting plasma total cholesterol ≥5.0
• Fasting plasma LDL cholesterol ≥3.0 and \<5.0 mmol/L.

You may not qualify if:

• Fasting plasma triglycerides ≥4.0 mmol/L
• Abnormal liver and kidney function
• Unstable body weight(\>3kg change in 3 months) or intention to lose or gain weight;
• Diabetes mellitus (fasting plasma glucose ≥7.0 mmol/L or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
• Use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
• Major surgical or medical events within the past 3 months;
• Presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
• Consumption of a diet containing ≥15% of energy from saturated fat;
• Any food allergy or aversion or unwillingness to eat wheat, soy or milk;
• Consumption of ≥5 servings per week of soy based food products;
• Consumption of an average of \>2 alcoholic beverages per day;
• Regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars

Sponsors & Collaborators

• Guelph Food Research Centre: lead
• University of Guelph: collaborator
• Glycemic Index Laboratories, Inc: collaborator
• Canadian Centre for Agri-Food Research in Health and Medicine: collaborator

Study Sites (3)

Canadian Centre for Agri-food Research in Health and Medicine

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Human Nutraceutical Research Unit. University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Glycemic Index Laboratories, Inc

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (13)

• Reinwald S, Akabas SR, Weaver CM. Whole versus the piecemeal approach to evaluating soy. J Nutr. 2010 Dec;140(12):2335S-2343S. doi: 10.3945/jn.110.124925. Epub 2010 Oct 27.

  PMID: 20980652 BACKGROUND

• Zhang X, Shu XO, Gao YT, Yang G, Li Q, Li H, Jin F, Zheng W. Soy food consumption is associated with lower risk of coronary heart disease in Chinese women. J Nutr. 2003 Sep;133(9):2874-8. doi: 10.1093/jn/133.9.2874.

  PMID: 12949380 BACKGROUND

• Kokubo Y, Iso H, Ishihara J, Okada K, Inoue M, Tsugane S; JPHC Study Group. Association of dietary intake of soy, beans, and isoflavones with risk of cerebral and myocardial infarctions in Japanese populations: the Japan Public Health Center-based (JPHC) study cohort I. Circulation. 2007 Nov 27;116(22):2553-62. doi: 10.1161/CIRCULATIONAHA.106.683755. Epub 2007 Nov 19.

  PMID: 18025534 BACKGROUND

• Nanri A, Mizoue T, Takahashi Y, Kirii K, Inoue M, Noda M, Tsugane S. Soy product and isoflavone intakes are associated with a lower risk of type 2 diabetes in overweight Japanese women. J Nutr. 2010 Mar;140(3):580-6. doi: 10.3945/jn.109.116020. Epub 2010 Jan 6.

  PMID: 20053935 BACKGROUND

• Yang B, Chen Y, Xu T, Yu Y, Huang T, Hu X, Li D. Systematic review and meta-analysis of soy products consumption in patients with type 2 diabetes mellitus. Asia Pac J Clin Nutr. 2011;20(4):593-602.

  PMID: 22094845 BACKGROUND

• Anderson JW, Bush HM. Soy protein effects on serum lipoproteins: a quality assessment and meta-analysis of randomized, controlled studies. J Am Coll Nutr. 2011 Apr;30(2):79-91. doi: 10.1080/07315724.2011.10719947.

  PMID: 21730216 BACKGROUND

• Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995 Aug 3;333(5):276-82. doi: 10.1056/NEJM199508033330502.

  PMID: 7596371 BACKGROUND

• Zhan S, Ho SC. Meta-analysis of the effects of soy protein containing isoflavones on the lipid profile. Am J Clin Nutr. 2005 Feb;81(2):397-408. doi: 10.1093/ajcn.81.2.397.

  PMID: 15699227 BACKGROUND

• Dewell A, Hollenbeck PL, Hollenbeck CB. Clinical review: a critical evaluation of the role of soy protein and isoflavone supplementation in the control of plasma cholesterol concentrations. J Clin Endocrinol Metab. 2006 Mar;91(3):772-80. doi: 10.1210/jc.2004-2350. Epub 2005 Dec 29.

  PMID: 16384855 BACKGROUND

• Sirtori CR, Eberini I, Arnoldi A. Hypocholesterolaemic effects of soya proteins: results of recent studies are predictable from the anderson meta-analysis data. Br J Nutr. 2007 May;97(5):816-22. doi: 10.1017/S0007114507670810.

  PMID: 17408521 BACKGROUND

• Sacks FM, Lichtenstein A, Van Horn L, Harris W, Kris-Etherton P, Winston M; American Heart Association Nutrition Committee. Soy protein, isoflavones, and cardiovascular health: an American Heart Association Science Advisory for professionals from the Nutrition Committee. Circulation. 2006 Feb 21;113(7):1034-44. doi: 10.1161/CIRCULATIONAHA.106.171052. Epub 2006 Jan 17.

  PMID: 16418439 BACKGROUND

• Klein MA, Nahin RL, Messina MJ, Rader JI, Thompson LU, Badger TM, Dwyer JT, Kim YS, Pontzer CH, Starke-Reed PE, Weaver CM. Guidance from an NIH workshop on designing, implementing, and reporting clinical studies of soy interventions. J Nutr. 2010 Jun;140(6):1192S-1204S. doi: 10.3945/jn.110.121830. Epub 2010 Apr 14.

  PMID: 20392880 BACKGROUND

• Padhi EM, Blewett HJ, Duncan AM, Guzman RP, Hawke A, Seetharaman K, Tsao R, Wolever TM, Ramdath DD. Whole Soy Flour Incorporated into a Muffin and Consumed at 2 Doses of Soy Protein Does Not Lower LDL Cholesterol in a Randomized, Double-Blind Controlled Trial of Hypercholesterolemic Adults. J Nutr. 2015 Dec;145(12):2665-74. doi: 10.3945/jn.115.219873. Epub 2015 Oct 7.

  PMID: 26446482 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alison Duncan, PhD, RD

  University of Guelph

  PRINCIPAL INVESTIGATOR

• Thomas Wolever, MD, PhD

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

• Heather Blewett, PhD

  Canadian Centre for Agri-Food Research in Health and Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 8, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

CA (3)